So, Why Can't I Find Something For My Child's Pain and Fever on the Shelves Anymore?

I am still hearing parents’ frustration when it comes to finding pain and fever relievers on the shelves for their child. Parent’s simply cannot find what they are looking for on the shelves. Unfortunately, it may get even more confusing to parents in the near future because US companies will cease making infant drop forms of these medications this year.

The problems all started in May, 2010. McNeil Consumer Healthcare, makers of Tylenol brand acetaminophen, did a massive recall of over 40 pain, fever and allergy medicines for children, including certain forms of:

• Tylenol Infants' Drops
• Children's Tylenol Suspension
• Children's Tylenol Plus Suspension
• Motrin Infants' Drops
• Children's Motrin Suspension
• Children's Motrin Cold Suspension
• Children's Zyrtec
• Children's Benadryl Allergy liquids in bottles.

The concerns that led to the recall were several including possibly higher than intended concentrations of active ingredients. McNeil also stated that some of the medications 'may contain inactive ingredients that may not meet internal testing requirements' or 'may contain tiny particles' and that some of the raw materials used to make the products were contaminated with bacteria. No bacteria were found in the finished products though. There was only one manufacturing plant involved, but all lots were recalled.

Many of McNeil’s products are still unavailable. You can get Children's Tylenol Grape Oral Suspension and Children's and Junior Strength Tylenol Meltaways, but other forms of liquid and chewable Tylenol and Motrin still aren't available. Children's Zyrtec syrup and Children's Benadryl Allergy Bubblegum Flavored Liquid Dye Free are also still unavailable.

Generic versions of acetaminophen (Tylenol), ibuprofen (Motrin), diphenhydramine (Benadryl), and cetirizine (Zytrec) are available from other companies to help treat kids with pain, fever, or allergies. There are also other flavors of Children's Benadryl Allergy liquid and Advil (another brand name ibuprofen product) available if you need them.
This brings us to the recent issue. In response to an expected FDA review later this month, several of the largest manufacturers have stated that they will cease to make infant drop versions of acetaminophen (Tylenol) containing pain and fever reducers and acetaminophen containing cold medicine drops as well.
The reason for this is that there have been reported cases of parents with children of varying ages accidentally dosing the concentrated infant drops as though they were the children’s liquid. The concentrations are quite different. The concentrated drops have been at a concentration of 80 mg per 0.8 ml’s (100 mg/ml). The children’s liquid has been at 160mg/tsp(5ml), which works out to be only 32 mg/ml. So, a parent could easily give 3 or 4 times the intended dose if they mixed up the two.
So, in the near future, a small baby who would have received 0.4 ml. of the infant drops will instead be given 1.25 ml (1/4 tsp) of the children’s formulation. A larger baby who would have received 0.8 ml. will get 2.5 ml.
Note that it is very important to dose these medications carefully. All of them will be packaged with a measuring device - dropper, syringe or spoon to make sure the correct dosage is given. Do not estimate doses with a household spoon as the amount can vary tremendously. One study showed that standard household eating utensil teaspoons can vary from 3 to over 7 ml.
In large doses, acetaminophen can be toxic to the liver. In big overdoses it can lead to liver failure and even death. Rest assured that if dosed appropriately, it is quite safe, even for use over several days - but getting the dose right is the key factor to its safety.




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